Vaginal Tactile Imager

Basic Information

• Brand Name: Vaginal Tactile Imager
• Primary DI: 00864124000106
• Version / Model: 2S
• Company Name: Advanced Tactile Imaging, Inc.
• Labeler DUNS: 078793844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-10
• Public Version: 2
• Public Version Date: 2021-03-25
• Public Version Status: Update
• Public Device Record Key: 11abcc42-d8d1-4652-9d10-05c54e653e98

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIR	Perineometer	Obstetrics/Gynecology	884.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61200	Pelvic floor tactile imaging system	A mobile, mains electricity (AC-powered) assembly of devices intended to quantitatively measure, map, and display pelvic floor elasticity/strength values (e.g., pressure mapping of pelvic floor structures, pelvic floor muscle strength during muscle contractions) to aid the diagnosis and evaluation of vaginal and pelvic floor conditions. It consists of a central analysis unit with dedicated software, a monitor, and a transvaginal probe with built-in pressure/motion sensors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864124000106	GS1

Premarket Submissions

Submission Number	Supplement Number
K142355	000